Derotational brace for treatment of idiopathic scoliosis

ABSTRACT

A brace for correction of scoliosis is disclosed, comprising at least one thoracic shell element and a pelvic shell element and at least one working element having a main longitudinal axle to be oriented parallel to the trunk to be treated, anchored on one of its opposite ends to the thoracic shell element and on the other to the pelvic shell element, and having spring characteristics adapted to apply continuous de-rotational force about said longitudinal axle.

FIELD OF THE INVENTION

The present invention generally relates to a de-rotation brace fortreatment of idiopathic scoliosis, and to a method for treatingscoliosis and idiopathic scoliosis.

BACKGROUND OF THE INVENTION

Scoliosis, known also by the terms idiopathic scoliosis, spinalcurvature and lardoscoliosis) is a deviation from a normal spine inthree directions or planes: frontal (coronal), lateral (sagittal) andtransversal (axial). While ten percent of the population will have somespinal curvature, no more than three promilles require extensive medicaltreatment. Scoliosis may be present due to underlying muscle or nerveproblems, a defect in bone formation or due to unknown reasons, i.e.,idiopathic scoliosis. Idiopathic scoliosis, and particularly itsadolescent type, may affect up to three percent of the adolescentpopulation. One treatment is provided by a scoliosis brace, which is anorthosis adapted to hold the spine in a straighter position. The braceis prescribed by an orthopedic specialist and is usually worn constantlyand continuously until bone growth has stopped.

As set forth above, scoliosis is a complex 3-D deformation of the trunk,spine and rib cage. From the clinical point of view, the most prominentfeature of this complex deformity is a sideward curvature of the trunkaccompanied by the rib's hump. In such cases a rib hump is still presentand even progresses with all its consequences. The list of clinicalproblems associated with scoliosis goes far beyond the pure cosmeticcomplaints. It includes a distortion of the abdominal and chest organsand therefore an alteration of their functional capabilities, alterationof a normal gait with associated pelvic obliquity and many otherfunctional and psychosocial difficulties.

Unlike congenital scoliosis, which is caused by congenital anomalies ofthe spinal structure, for the idiopathic type of scoliosis no congenitalanomalies of vertebras or rib cage are identified. This may partiallyexplain the fact that to date, despite numerous attempts to identify theexact cause for this pathology it has not been not found. Therefore, theevaluation of medical methods of treatment is complicated and oftenempirical, and is based on the personal experience and beliefs of thesurgeon. In fact, the principals of treatment of scoliosis have remainedbasically unchanged for the last 70 years.

Inventions disclosed in the art basically include different kinds ofdevices that permit some preservation of the natural spinal movementwithout compromising the stable holding properties of the fixationsystem.

Idiopathic scoliosis is not an acute illness, but with time thevertebrae become secondarily deformed. Surgeons who treat scoliosis knowabout the deformation of the scoliotic vertebrae, this deformity isespecially prominent in computer tomography evaluation. Apical vertebraeare the most deformed and they appear twisted on the axial CT images.

It is acknowledged that less then ten percent of patients withidiopathic scoliosis will need a surgical correction. Fortunately, mostof the patients are diagnosed during the early stage of the scolioticprogression and can be treated conservatively. For this purpose,different types of externally applied corrective devices were developed.

The idea of bracing for scoliosis treatment dates back to ancient times.Many attempts to stop the progression of structural scoliotic curveswere performed in the past: forcible horizontal traction and suspension,corsets, casts and a variety of braces.

Long-term follow-up studies of patients treated with the Milwaukee-likebraces indicate that the main effect of the brace is to halt theprogression of moderate-degree scoliotic curves. U.S. Pat. No. 4,230,101to Gold for example introduces an improved Milwaukee-style bracecomprising upright metal bars and small straps that apply pressure tothe spine. One of the well-known problems with this treatment is theissue of compliance with brace wear.

The Boston brace system was introduced in 1971 by John Hall and BillMiller and is known worldwide as the standard for brace treatment. It isdesigned to be “active” by means of constantly applied de-rotationforces, but these forces are produced by the static arrangement of thepads. U.S. Pat. No. 5,503,621 to Miller for example discloses a bodybrace which is a Boston-style brace made of a plastic body jacket thatfits snugly around the body to exert pressure on the ribs and back,pushing the spine into a straighter position. These braces areconsiderably uncomfortable corset-like orthosis that apply non-constantand scattered twisting forces on the body of the patients. Moreover,permanent loss of the natural flexibility of the spine because of thesolid fusion of the spinal column is the price paid to protect thesurgically achieved correction. The data suggests that part-time braceuse sometimes may be as effective as full-time use. Complete failure touse the brace, however, has an adverse prognosis. Control or netcorrection of idiopathic scoliosis treated by this brace was achieved inapproximately 80% of the patients. But control of the curves with apexesabove T7, triple curves, and curves in excess of 45 degrees appearedpoor.

The Charleston bending brace, designed to be worn during sleep, wasintroduced in 1989 as an alternative to upright bracing but theeffectiveness of the Charleston bending orthosis is even lower than theBoston brace. The average effectiveness for different types of bracingis 50% but compliance is suggested in the literature to be lower thanfor the Milwaukee brace.

Current indications for bracing scoliosis include children with at leastone year or more of growth remaining, with curves of between 25 and 40degrees and with apex of T8 or below and approximately 50% flexibility(Boston Brace course). In a prospective study of adolescent idiopathicscoliosis, female patients with curves between 25 and 35 degrees weretreated with an underarm plastic brace. A successful outcome wasobtained in 74% (curve progression no more than 5 degrees) compared to34% of those who had no treatment. With increasing severity of theinitially detected curve the prognosis for the outcome is worse.

Only recently have investigators began to search for true dynamic typesof braces. One example of this may be the TriaC™ brace with a system ofstraps, but the amount of corrective forces that can be generated bythis brace is limited and probably needs constant adjustment foreffective use.

U.S. Pat. No. 5,599,286 to Labelle et al. discloses an elasticde-rotating orthopedic device, which applies a rotational force by meansof stretchable strip or a plurality of such rubber-like strips. Thiscorset is not strictly and firmly affixed to the body of the patient andthus applies for unfocused rotatory forces. Moreover, those forces arenot homogenous and tend to decrease as time follows. Lastly, U.S. Pat.No. 5,840,051 to Towsley presents a flexible back and shoulderorthopedic brace for spinal applications. This orthosis contains bodystraps that are immobilized by an elongated trunk made of metalvertebrates stack affixed by means of two threaded poles. The spine ofthe patient is extended and pulled by the device along the mainlongitudinal axis of the device and only minimal rotatory forces areapplied.

A cost-effective and convenient scoliosis brace, adapted for every dayuse which provides for pure and highly focused rotational forces at apredetermined and constant measure thus meets a long felt need.

SUMMARY OF THE INVENTION

The main difference between the brace according to the present inventionand other types of braces is that in the currently presented brace, aconsiderable amount of the corrective de-rotational force is generatedby a superstructure having as a key part a linear spring (or springloaded) member applying a continuous corrective de-rotational forceabout its longitudinal axis, between an upper and a lower brace parts.

It is thus one embodiment of the present invention to provide a braceuseful for providing a controlled and progressive correction of thescoliosis by using pure derotational forces (that can be determinedduring treatment by placing spring member having a force appropriate forthe current condition of the spine), while retaining a high degree offreedom in 3-D movement of the spinal trunk of the patient (i.e.,‘scoliosis brace’). This novel efficient scoliosis brace is divided intoat least two parts, each of which is denoted hereto in the term ‘shellelement’. The brace is hence characterized by (i) a static braceassembly comprising an upper and lower brace parts (hereinafter will bereferred to also as thoracic shell and pelvic shell elements,respectively) ; and, (ii) a working element having a main longitudinalaxle to be oriented parallel to the trunk to be treated, anchored on oneof its opposite ends to the thoracic shell and on the other to thepelvic shell.

The aforementioned working element has spring characteristics (or isspring loaded) adapted to apply continuous derotational forces aboutsaid longitudinal axle while retaining at least a partial freedom forcoronal or sagittal movements of the patient.

Thus the present invention provides a brace for correction of scoliosiscomprising:

-   -   a. at least one static thoracic shell element;    -   b. at least one static pelvic shell element; and,    -   c. at least one working assembly comprising a working element,        having a main longitudinal axle to be oriented parallel to a        trunk of the patient to be treated, said working element being        anchored at one of its ends to the thoracic shell element and        being anchored in its other end to the pelvic shell element;    -   wherein said working element has spring characteristics (or is        spring loaded) adapted to apply continuous derotational forces        about said longitudinal axle while retaining at least a partial        freedom for coronal or sagittal movements of the patient.

It is also in the scope of the present invention to provide thehereto-defined brace, which is adapted to treat multi-apex types ofscoliosis. This brace comprises a static brace assembly comprising apelvic shell element and a plurality of 2 or 3 thoracic shell elementswith at least one working element connecting between each shell elementand another shell element.

According to one preferred embodiment the working element ischaracterized by comprising a twistable spring-like plate. The inventionwill be further described as using such spring type, although it is notlimited to a plate type spring. A helical spring, a rod shaped spring,or any other type of spring capable of applying corrective de-rotationalforce about a longitudinal axle lying parallel to a patient trunk couldbe used as well without departing from the scope of the presentinvention. Moreover, the working assembly may be comprised of aplurality of working elements, arranged in bundles, stacks or located inan array of parallel elements.

It is also in the scope of the present invention, wherein the workingassembly comprises at least two sets of anchoring assembly, eachanchoring assembly comprises the following three ingredients: (i) ananchoring device; (ii) a set of lower and upper clutches, and (iii), atleast one fastening screw. The anchoring device is adapted to beimmobilized firmly to the thoracic shell, or to the pelvic shell eitherdirectly or through any other additional component. The set of lower andupper clutches is adapted to clasp the working element, in a recessformed in between, the width of said recess is adapted to receiving thewidth of the working element with a small surplus gap on both sides ofthe working element. Lastly, the fastening screw connects between saidanchoring device, said lower clutch, working element and said upperclutch in such a manner that a planar hinge is provided, enabling theworking element to transmit a corrective de-rotational force which actsto pivot the anchoring assembly and in turn the surface of the brace towhich it is attached, in the desired direction for correcting thescoliosis while, said working element can pivot in a limited courseabout said fastening screw and parallel to the patient back, due to thesmall surplus gap in the recess, on both sides of the working element.This pivoting of the working element is useful for providing the patientwith some freedom in the lateral movements of his back and for allowinga correction of the posture by allowing the patient spine to straightenduring the treatment period when the top of the patient back is broughtto a more straight position, above its bottom.

It is another object of the present invention to provide a mostconvenient and effective method for treating scoliosis by means of thescoliosis brace as defined in any of the above. After measuring curvedimensions and magnitude (by any acceptable measuring method e.g. onroentgen photos or through infra-red measuring methods) as a primarystep for determining whether a specific patient is to be treated(according to scoliosis seriousness with respect to acceptablestandards), this method comprises the following steps: (i) adapting apelvic shell and a thoracic shell for a patient to be treated; (ii)adapting a working element to be connected between the shells; (iii)anchoring the working element between the shells to form a scoliosisbrace; (iv) dressing the patient with the brace for a certain number ofhours a day (e.g. 15 hours or e.g. 17 hours) such that the workingelement transmits a continuous corrective de-rotational force to thepatient trunk through the brace shells; (v) tracing the patient fromtime to time as a follow-up for determining the scoliosis state, andreplacing the working element if need rises for changing the correctivede-rotational force.

According to one embodiment of the method according to the presentinvention, the step of adapting a pelvic shell and a thoracic shell fora patient to be treated is performed by (a) enveloping the patient witha soft cast, in such a manner that it encompasses the patient from thepelvis and upwards, along the spinal trunk; (b) dividing said castedwhole brace to form thoracic and pelvic brace portions; (c) shaping saidthoracic and pelvic brace portions (so as to form shells having contactareas with the patient body useful for transmitting pressures asuniformly as can be achieved, and adapted to the patient body, e.g. byminimizing (cutting) the brace area in the regions were the workingelement is not intended to affect a pressure, or e.g. cutting the braceregion facing the breast in case of a female patient; (d) cutting saidshaped thoracic and pelvic brace portions, so a side opening isprovided, allowing for removal of the brace from the patient body; (e)fitting zippers or other closing arrangements on the rims of saidopenings; (f) connecting anchoring devices on the shells and (g)clutching a working element by said anchoring devices.

According to various embodiments of the present invention any of thebrace upper and lower portions may further be provided with areinforcement strip extended from the connection region between theanchoring device and the brace along certain regions of the brace andaimed to divide the pressure transmitted from the working element to theshell element at their connection over a wider area of the shellelement. The reinforcement strip can be incorporated to the brace insidethe cast as an inner layer of the shell element, or on its surface, andit could be made of any elastic material, e.g. a plastic strip, or athin steel strip.

Thus, according to one enbodiment the present invention provides amethod for treating scoliosis, comprising;

-   -   a. enveloping the patient with a soft cast, in such a manner        that it encompasses the patient from the pelvis and upwards,        along the spinal trunk;    -   b. dividing said casted whole brace to form thoracic shell        element and a pelvic shell;    -   c. optionally shaping said thoracic and pelvic shell elements to        a desired shape (e.g. for improving pressure distribution, or        e.g. when the shape received by the casting comprise surplus        portions which may unnecessarily disturb the patient);    -   d. cutting said thoracic and pelvic shell elements, so a side        opening is provided on each;    -   e. fitting attachers on the rims of said openings;    -   f. connecting anchoring elements to the thoracic and pelvic        shell elements; and,    -   g. clutching a working element having a main longitudinal axle        parallel to a trunk of the patient to be treated, to said        anchoring devices in a manner that said working element has        spring characteristics adapted to apply continuous derotational        forces along the said longitudinal axle while retaining at least        a partial degree of freedom for coronal or sagittal movements of        the patient wearing the brace.

According to another embodiment the present invention provides a methodfor treating scoliosis, comprising;

-   -   a. enveloping the patient with a soft cast, in such a manner        that it encompasses the patient at the pelvis area to form a        pelvic shell element;    -   b. enveloping the patient with a soft cast, in such a manner        that it encompasses the patient at the thoracic area, to form a        thoracic shell element;    -   c. optionally shaping said thoracic and pelvic shell elements to        a desired shape (e.g. for improving pressure distribution, or        e.g. when the shape received by the casting comprise surplus        portions which may unnecessarily disturb the patient);    -   d. cutting said thoracic and pelvic shell elements, so a side        opening is provided on each;    -   e. fitting attachers on the rims of said openings;    -   f. connecting anchoring elements to the thoracic and pelvic        shell elements; and,    -   g. clutching a working element having a main longitudinal axle        parallel to a trunk of the patient to be treated, to said        anchoring devices in a manner that said working element has        spring characteristics adapted to apply continuous derotational        forces along the said longitudinal axle while retaining at least        a partial degree of freedom for coronal or sagittal movements of        the patient wearing the brace.

According to another embodiment the present invention provides a methodfor treating scoliosis, comprising;

-   -   a. adapting a prefabricated pelvic shell element to a patient to        be treated, from a plurality of measures of prefabricated pelvic        shell elements;    -   b. adapting a prefabricated thoracic shell element to a patient        to be treated, from a plurality of measures of prefabricated        thoracic shell elements;    -   c. optionally shaping said thoracic and pelvic shell elements to        a desired shape (e.g. for improving pressure distribution, or        e.g. when the shape received by the casting comprise surplus        portions which may unnecessarily disturb the patient);    -   d. adapting a working element to the patient to be treated;    -   e. clutching the working element to anchoring devices connected        to said shell elements in such that spring characteristics of        said working element apply continuous derotational forces along        a longitudinal axle of the working element while retaining at        least a partial degree of freedom for coronal or sagittal        movements of the patient.

It is yet in the scope of the present invention to provide a methodespecially adapted for treating multi-apex type scoliosis. By thisaspect the method is directed also to a case wherein, a plurality 2 or 3thoracic shell elements are provided (either by selecting and adaptingthem to the patient from a plurality of measures of prefabricated shellelements, or by casting them on the patient body either separately or asone casting then dividing it by cutting) and wherein each of thethoracic shell elements is connected to another or to a pelvic shellelement through a working element.

BRIEF DESCRIPTION OF THE INVENTION

In order to understand the invention and to see how it may beimplemented in practice, a preferred embodiment will now be described,by way of non-limiting example only, with reference to the accompanyingdrawing, in which

FIG. 1 schematically presents a side view of a patient wearing thescoliosis brace according to one embodiment of the present invention;

FIG. 2 schematically presents a top view of the working assembly in arest conformation;

FIG. 3 schematically presents a top view of the same working assembly ina rotated conformation;

FIG. 4 schematically presents a front view of a patient back with ascoliosis brace according to said embodiment of the present invention;

FIG. 5 schematically presents a top view of a patient wearing ascoliosis brace according to said embodiment of the present invention;

FIG. 6 schematically presents a top view, a lateral cross section andperspective view of the various ingredients of the anchoring assembly ofthe working assembly;

FIG. 7 schematically presents a lateral cross section of the assembledanchoring assembly of the working assembly;

FIG. 8 schematically presents a front view of the whole scoliosis brace;

FIG. 9 schematically presents a front view of the divided scoliosisbrace;

FIG. 10 schematically presents a front view of the shaped scoliosisbrace;

FIG. 11 schematically presents a side view of a patient wearing thescoliosis brace, wherein said brace contains side openings;

FIG. 12 schematically presents a top view of the scoliosis bracecontaining side openings in open and closed configurations;

FIG. 13 schematically presents a side view of a patient wearing thescoliosis brace, wherein said brace contains zippers; and,

FIG. 14 schematically presents a front view of a patient wearing thescoliosis brace, wherein the anchoring devices are immobilized on top ofthe two portions of the brace.

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided, alongside all chapters of thepresent invention, so as to enable any person skilled in the art to makeuse of said invention and sets forth the best modes contemplated by theinventor of carrying out this invention. Various modifications, however,will remain apparent to those skilled in the art, since the generalprinciples of the present invention have been defined specifically toprovide a scoliosis brace useful for providing a controlled andprogressive correction of the scoliosis by using pure derotationalforces, while retaining a high degree of freedom in 3-D movement of thespinal trunk of the patient.

The term ‘idiopathic scoliosis’ refers in the present invention to anymalfunction of the trunk and/or the spinal column and to the variousvariants and subtypes, especially adolescent scoliosis.

The term ‘the brace’ refers in the present invention to any orthosis ashereto described and defined, adapted to treat said idiopathic scoliosisby means of a brace having a working element characterized by springproperties that inter alia are adapted to apply pure and constantderotational (i.e. either rotational and/or derotational) forces.

The invention thus includes two major parts: a dynamic brace, which isadapted for treatment of adolescent idiopathic scoliosis; and means thatare adapted to provide a controlled progressive correction of thescoliosis by using pure derotational forces produced by the said dynamicbrace.

The aforementioned brace comprises two major assemblies: a staticassembly made from a thoracic and pelvic shell elements both elementsare adapted to anchor the orthosis to the patient; and a workingassembly comprising at least one working element having springproperties.

The static assembly is comprised of an external shell, built from twoseparate units: thoracic (i.e., upper) unit and pelvic (i.e., lower)unit. These two units are made of any kind of suitable materialincorporating both significant elasticity and noticeable rigidity, e.g.,high-density polypropylene (HDPP) polymer or copolymer, polyurethanecontaining thermosetic/thermoplastic polymers or copolymers etc. Thisexternal shell is removable by a means of at least one lateral opening.

The working assembly comprises at least one principal working element,which is in communication with at least two connecting devices, onelocated in the upper portion of the element and the second located inits lower portion. Said working element is characterized by springproperties that produce a rotational effect on the spine.

The working element connects between the two units of the externalshell. To achieve a continuous (e.g., constant and homogenous) effect ofderotation, the plate is molded in a twisting manner and then fixed byits ends to the anchoring parts of the device. The spring properties andrebound effect of the working element permit the continuous dynamicderotational effect on the trunk and the spinal column. The fixation ofthe working element to the external shell units is designed in such away that free movements of the trunk are preserved.

According to another embodiment, the working element is characterized bya rigid pole like member located parallel to the trunk to be treated.Said rigid pole-like member is in communication with at least oneworking member (e.g., a spring, a torque pole etc). Said working memberis either integrated to the pole-like member, or located at the end ofthe pole-like member, at the joint connecting the said pole-like memberand one of the brace's shells. According to another embodiment, therigid working element is exceeded to two spring-like units, each ofwhich located in an end of the member in such a manner that itinterconnects said element with the thoracic shell and the pelvic shell.

The measure of derotational forces applied may be adjusted during thefollow up period by exchanging the working element by another one with adifferent thickness or stiffness (i.e. resulting in different springcharacteristics). The other way to change the amount of de-rotationalforces is to adjust the degree of the initial twisting of thelongitudinal spring plate. The design of the device will permitpreservation of almost all of the natural mobility of the trunk. Thedesign of the brace allows a free sideway translation of the shouldersand upper back relative to the lower back and pelvis during thetreatment process. This quality is essential to improve the spinalbalance in cases of unbalanced spine at the beginning of the treatmentprocess.

Reference is made now to FIG. 1, presenting a schematic side view of theidiopathic scoliosis according to one embodiment of present inventioncomprising a working assembly (1) located in an erect orientationadjacent to the truck. The working assembly (1) is anchored to the twoparts of the static assembly, e.g., the thoracic shell (2) and thepelvic shell (3).

Reference is made now to FIG. 2, presenting a top view of the workingassembly (3) comprising a working element (20) and two anchoring devices(21) and (26). It is according to one preferred embodiment of thepresent invention wherein the working element is characterized by alinear plate shape having an approximately rectangular shape or anyother polygonal shape. Nevertheless, it is well in the scope of thepresent invention wherein said working assembly comprises a plurality ofN working elements, wherein N is an integer number between 1 to 100, andfurther wherein the working element is characterized by a shape selectedfrom polygonal, rounded, spring-like or any combination thereof. Theworking element is made of metal alloy, stainless steel, polymers,composite materials or any combination thereof. Its dimensions may varyfrom a few centimeters to about 75 cm, preferably its length isapproximately equal to the distance between the thoracic portion and thepelvic portion of the back of the patient. The linear plate-like workingassembly may be characterized by a stack conformation, whereat aplurality of leaf-like plates are stacked together. Additionally oralternatively, the working element is a bundle of pole-like elements,wherein the number of the elements determines both the elasticity andthe derotational forces characterizing the working element.

Reference is still made to FIG. 2, presenting the anchoring devices (21)and (26) that are attached to the working element (20) by means of thelower and upper clutch members (23, 24), respectively and lower andupper clutch members (29, 28), respectively. The anchoring devices (21,26) include the means to be firmly entrapped to the brace, e.g., bymeans of 6 screws of fasteners located in holes such as those denoted insigns (22A) and (27A). Upper clutch member (24) is firmly attached toone end portion of the working element (20), to the lower clutch member(23) and to anchoring device (21) by means of a screw (25A), by aplurality of fasteners or by any other reversible means. Similarly,upper clutch (29) is fastened to the opposite portion of the workingelement (20), to the lower clutch (28) and to the anchoring device (26)by a means of a screw (25B).

Reference is made now to FIG. 3, presenting a top view of the saidworking assembly (1), wherein the working element (20) is rotated sothat the thoracic portion is twisted towards the left direction (31)while the pelvic portion is forced towards the right direction (32).

Reference is made now to FIG. 4, presenting a view of a patient's backhaving a typical scoliosis to be treated. Said patient is wearing thescoliosis brace according the present invention. The thoracic portion ofthe back is thus forced in the corrective direction shown by arrow (42)while the pelvic portion is forced in the corrective direction shown byarrow (44) by means of the linear working element (20), which isattached on its upper portion to the thoracic shell of the brace (41),and in its lower portion to the pelvic shell of the brace (43). It isacknowledged that one or more of the brace's portion may be shaped in anunequal manner. Hence, the right portion of the thoracic brace ischaracterized by significantly more surface area, while the left portionof the pelvic brace (43) is wider than its right portion, such that theportions of the brace which transmit the force of the working element tothe patient body are made wider for more even distribution of the forcesacting on the patient body. From the same reason, in the frontal side ofthe brace shells (hidden in this figure by the patient body), thethoracic shell of the brace has a larger area on its left side comparingto the area on its right, and the pelvic shell of the brace has a largerarea on its right side comparing to the area on its left, since thedirection of the forces on the frontal portions of the brace shells actin a similar tendency with the forces on the rear side, i.e. exertingforces on the left of the patient chest and on the right of its pelvis.More even circumferential distribution of the forces acting on thepatient body is thus provided.

FIG. 5 schematically presents the same patient and brace illustrated byFIG. 4, from a top view. The thoracic shell member of the brace isforced by the working element in the direction shown by the arrow (42)while the pelvic shell member of the brace is forced by the workingelement in the direction shown by arrow (44).

Reference is made now to FIG. 6 and 7, presenting the anchoring assemblyfrom top view, perspective view and in a lateral cross section.According to yet another embodiment of the present invention, theanchoring device (60) is characterized by a rectangular shape comprisinga plurality of bores (e.g., 22A) adapted to fit screws or any otherfastening members. Those screws or other fasteners immobilize theanchoring device to the brace. If the rotational forces are directedrightwards, the lower (61) and upper (65) clutches are located somewhatleftwards from the center of the anchoring device (60) and vice versa,providing for maximum lever means to the working element (not shown).Said working element is adapted to be accommodated in between the lower(61) and upper (65) clutches while a fastening screw (66) is lockedfirmly in said “sandwich”. The lower clutch (61) is preferably comprisedof a recess (62), wider than the width of the working element, so theelement has a predetermined freedom to rotate about the fastening screw(66) due to gaps (62a) and (62b) on both sides of the working element,as can be seen in FIG. 7. Said recess is defined by a plurality ofprotrusions (63) and (64), that fit to one or more recesses located onthe upper clutch (65). While the upper surface of the anchoring plate islinear, its lower surface, facing the brace, may be non-linear, e.g.,curved, having a trapeze-like shape etc. Reference is made now to FIG.7, presenting the anchoring assembly from a lateral cross section view,wherein the working element (20) is accommodated in between the lower(61) and upper (65) clutches by means of a fastening screw (66), henceaffecting the anchoring device (60) to be twisted towards apredetermined direction.

Reference is made now to FIGS. 8 to 14, presenting lateral views, sideview and top view of a patient wearing the scoliosis brace according topresent invention. These Figures also present at least one embodiment ofthe method for using said novel scoliosis brace as defined and describedin the present invention.

After measuring the scoliosis curve dimensions and its magnitude, thecharacteristics of the working element are calculated and said elementis adapted to the patient to be treated. Said measurement of the spineis usually provided by CT scans, X-ray pictures etc. Reference is madenow to FIG. 8, presenting the step whereat the patient is enveloped witha soft cast. The term “soft cast” refers in the present invention to anycommercially available soft cast materials; gypsum or any othergypsum-like materials; plastics and polymers such as HDPP, polylacticacid (PLA) derivatives, polyurethanes; rubbers; composite materials;cloth or fabrics; metal frames or any combination thereof. The brace maybe made from a continuous material or may comprise a plurality of holesand openings. Said newly formed envelope (80) encompasses the patientfrom his pelvis and upward, along the entire length of the spinal trunk.

Reference is made now to FIG. 9, presenting the step whereat the castedwhole brace is divided into at least two portions: to form a thoracicbrace (81) and a pelvic brace (82). It is in the scope of the presentinvention wherein said divided cast comprises three or more portions.This multi-portional brace may be provided in treatment of patientshaving more than one curve.

Reference is made now to FIG. 10, presenting the step of shaping thethoracic brace and/or a pelvic brace in an unequal manner, so thesurface of the brace is wider along the direction of the derotetionalforces. Subsequently, reference is made to FIG. 11, presenting the stepof putting inserting those shaped portions of the brace in its side, sothat side openings (111) and (112) are provided. Those openings are alsoillustrated in FIG. 12 in a top view, showing a closed and an openconformation of the sliced brace.

Reference is made now to FIG. 13, presenting yet another side view ofthe patient the step of fitting a plurality of attachers (131) and (132)on the rims of said openings. Those attachers may be selected fromzippers, laces, commercially available Velcro zippers, buckles, claspsetc.

Reference is made now to FIG. 14, presenting a front view of thepatient, whereat the anchoring device (60) are immobilized on top of thetwo portions of the brace (141 and 142). Optionally, at least oneenforcing strip (143) is now provided to support one or more portions ofthe brace.

Finally, the working element is clutched by means of the immobilizedanchoring devicesand clutches and the pure and constant de-rotatoryforces are applied towards specifically determined locations along thepatient's curved trunk.

1. A brace for correction of scoliosis comprising at least one thoracicshell element and a pelvic shell element and at least one workingelement having a main longitudinal axle to be oriented parallel to thetrunk to be treated, anchored on one of its opposite ends to thethoracic shell element and on the other to the pelvic shell element, andhaving spring characteristics adapted to apply continuous derotationalforce about said longitudinal axle.
 2. A brace according to claim 1,comprising a plurality of thoracic shell elements and a plurality ofworking elements.
 3. A brace according to claim 1, wherein the workingelement is a twistable spring-like plate.
 4. A brace according to claim1, comprising a plurality of working elements arranged in bundles,stacks or located in an array of parallel elements.
 5. A brace accordingto claim 1, wherein the at least one working element is a part of aworking assembly comprising at least two sets of anchoring assemblies,each of which comprises; a. an anchoring device adapted to beimmobilized on the thoracic shell element, the pelvic shell element orany other brace portion; b. a set of lower and upper clutches adapted toclasp the working element in a recess formed in between and adapted toreceiving the end of the working element with a surplus gap on bothsides,; and c. a fastening screw, communicating between said anchoringdevice, said lower clutch, working element and said upper clutch in sucha manner that a planar hinge is provided; so said working element isfree to pivot around said hinge in a controlled course, parallel to thepatient back.
 6. A brace according to claim 1, wherein the workingelement is a rigid pole-like member located parallel to the trunk to betreated; said rigid pole-like member is in communication with at leastone working member which is either integrated to said pole-like member,or located at the end of the pole-like member in such a manner that itconnects the said pole-like member with one of the brace's shellelements.
 7. A brace according to claim 6, wherein the rigid workingelement is exceeded to at least two spring-like derotation units in sucha manner that at least one unit connects the upper end portion of themember with the thoracic shell and at least one unit is connects thelower end portion of the member with the pelvic shell.
 8. A method fortreating scoliosis, comprising; (i) adapting a scoliosis bracecomprising a pelvic shell and a thoracic shell to a patient to betreated; (ii) adapting a working element to be connected between theshells; (iii) anchoring the working element between the shells to form ascoliosis brace; (iv) dressing the patient with the brace for a certainnumber of hours a day such that the working element transmits acontinuous corrective de-rotational force to the patient trunk throughthe brace shells; (v) tracing the patient from time to time as afollow-up for determining the scoliosis state, and replacing the workingelement if need rises for changing the corrective de-rotational force.9. A method for treating scoliosis according to claim 8, wherein theadaptation of the scoliosis brace to the patient is made by casting thepelvic shell or the thoracic shell on the patient body.
 10. A method fortreating scoliosis according to claim 8, wherein the adaptation of thescoliosis brace to the patient is made by selecting appropriate shellsfrom a plurality of measures of prefabricated shells.
 11. A method fortreating scoliosis according to claim 8, wherein for treating multi-apextype scoliosis a plurality of thoracic shell elements and of workingelements are used.